Lupin receives approval from U.S. FDA for Varenicline Tablets

Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Varenicline Tablets, 0.5 mg and 1 mg, to market a generic equivalent of Chantix® Tablets, 0.5 mg and 1 mg, of PF Prism C.V. The product will be manufactured at Lupin's Pithampur facility in India.

Varenicline Tablets, 0.5 mg and 1 mg are indicated for use as an aid to smoking cessation treatment. Varenicline Tablets (RLD Chantix®) had estimated annual sales of USD 430 million in the U.S. (IQVIA MAT October 2023).

Shares of Lupin Limited was last trading in BSE at Rs. 1258.70 as compared to the previous close of Rs. 1260.15. The total number of shares traded during the day was 22773 in over 1402 trades.

The stock hit an intraday high of Rs. 1272.50 and intraday low of 1254.25. The net turnover during the day was Rs. 28814999.00.

Source : Equity Bulls

Keywords

Lupin INE326A01037 USFDA Aproval ANDA VareniclineTablets